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The trial will evaluate the safety and efficacy of 3 dose regimens of H-1337 [0.6% twice daily (b.i.d.), 1.0% b.i.d. and 1.0% once in the morning (q.a.m.), and timolol maleate (0.5%, b.i.d.) in both eyes for 28 days.](streamdown:incomplete-link)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| H-1337 0.6% Ophthalmic Solution b.i.d. | Experimental | One drop H-1337 twice daily in the study eye for 28 days |
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| H-1337 1.0% Ophthalmic Solution b.i.d. | Experimental | One drop H-1337 twice daily in the study eye for 28 days |
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| H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | Experimental | One drop H-1337 every morning and matching placebo every evening in the study eye for 28 days |
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| Timolol 0.5% Ophthalmic Solution b.i.d. | Active Comparator | One drop Timolol twice daily in the study eye for 28 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H-1337 0.6% | Drug | ophthalmic solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy as Assessed by Change in Intraocular Pressure | Mean change in intraocular pressure from baseline on Day 28 compared to timolol | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy as Assessed by Intraocular Pressure | Percentage of subjects reaching target intraocular pressure (≤18 mmHg) at each time point | Day 0, Day 1, Day 7, Day 14, and Day 28 |
| Safety as Assessed by Adverse Event Reporting |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other inclusion/exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| El-Roy Dixon, MD | Dixon Eye Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Global Research Management | Glendale | California | 91204 | United States | ||
| Skyline Vision Clinic and Laser Center |
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A 49-day screening period (screening visit plus washout period) occurred prior to randomization and the treatment period.
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| ID | Title | Description |
|---|---|---|
| FG000 | H-1337 0.6% Ophthalmic Solution b.i.d. | One drop H-1337 twice daily in the study eye for 28 days H-1337 0.6%: ophthalmic solution |
| FG001 | H-1337 1.0% Ophthalmic Solution b.i.d. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 19, 2024 | Jul 17, 2025 |
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| H-1337 1.0% |
| Drug |
ophthalmic solution |
|
| H-1337 Placebo | Drug | ophthalmic solution |
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| Timolol 0.5% | Drug | ophthalmic solution |
|
Percentage of participants with ocular and systemic adverse events
| Screening through Day 28 |
| Colorado Springs |
| Colorado |
| 80907 |
| United States |
| Central Florida Eye Associates | Lakeland | Florida | 33805 | United States |
| Shettle Eye Research, Inc. | Largo | Florida | 33773 | United States |
| Dixon Eye Care | Albany | Georgia | 31701 | United States |
| Coastal Research Associates, LLC | Roswell | Georgia | 30076 | United States |
| Rochester Ophthalmological Group, PC | Rochester | New York | 14618 | United States |
| University Eye Specialists | Maryville | Tennessee | 37803 | United States |
| Vistar Eye Center | Roanoke | Virginia | 24011 | United States |
One drop H-1337 twice daily in the study eye for 28 days
H-1337 1.0%: ophthalmic solution
| FG002 | H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | One drop H-1337 every morning and matching placebo every evening in the study eye for 28 days H-1337 1.0%: ophthalmic solution H-1337 Placebo: ophthalmic solution |
| FG003 | Timolol 0.5% Ophthalmic Solution b.i.d. | One drop Timolol twice daily in the study eye for 28 days Timolol 0.5%: ophthalmic solution |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | H-1337 0.6% Ophthalmic Solution b.i.d. | One drop H-1337 twice daily in the study eye for 28 days H-1337 0.6%: ophthalmic solution |
| BG001 | H-1337 1.0% Ophthalmic Solution b.i.d. | One drop H-1337 twice daily in the study eye for 28 days H-1337 1.0%: ophthalmic solution |
| BG002 | H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | One drop H-1337 every morning and matching placebo every evening in the study eye for 28 days H-1337 1.0%: ophthalmic solution H-1337 Placebo: ophthalmic solution |
| BG003 | Timolol 0.5% Ophthalmic Solution b.i.d. | One drop Timolol twice daily in the study eye for 28 days Timolol 0.5%: ophthalmic solution |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Iris Color | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy as Assessed by Change in Intraocular Pressure | Mean change in intraocular pressure from baseline on Day 28 compared to timolol | Intent-to-Treat (ITT) is defined as all randomized subjects. | Posted | Mean | Standard Deviation | mmHg | Day 28 | study eyes | study eyes |
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| Secondary | Efficacy as Assessed by Intraocular Pressure | Percentage of subjects reaching target intraocular pressure (≤18 mmHg) at each time point | Intent-to-Treat (ITT) is defined as all randomized subjects. | Posted | Number | 95% Confidence Interval | percentage of subjects | Day 0, Day 1, Day 7, Day 14, and Day 28 | study eyes | study eyes |
| |||||||||||||||||||||||||||||
| Secondary | Safety as Assessed by Adverse Event Reporting | Percentage of participants with ocular and systemic adverse events | Safety population is defined as all randomized subjects who received at least one dose of investigational product. | Posted | Number | 95% Confidence Interval | percentage of subjects | Screening through Day 28 |
|
28 days
Treatment-emergent adverse events (TEAE) are defined as AEs starting on or after the first dose of IP. A pre-existing event that worsens in severity after receiving the first dose of IP is treated as a new TEAE with date of onset set to the date of the increased severity.
An ocular event is an event where the site of the event is reported as both eyes (OU), right eye (OD) or left eye (OS).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | H-1337 0.6% Ophthalmic Solution b.i.d. | One drop H-1337 twice daily in the study eye for 28 days H-1337 0.6%: ophthalmic solution | 0 | 51 | 0 | 51 | 19 | 51 |
| EG001 | H-1337 1.0% Ophthalmic Solution b.i.d. | One drop H-1337 twice daily in the study eye for 28 days H-1337 1.0%: ophthalmic solution | 0 | 51 | 0 | 51 | 28 | 51 |
| EG002 | H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m. | One drop H-1337 every morning and matching placebo every evening in the study eye for 28 days H-1337 1.0%: ophthalmic solution H-1337 Placebo: ophthalmic solution | 0 | 50 | 0 | 50 | 29 | 50 |
| EG003 | Timolol 0.5% Ophthalmic Solution b.i.d. | One drop Timolol twice daily in the study eye for 28 days Timolol 0.5%: ophthalmic solution | 0 | 49 | 0 | 49 | 8 | 49 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | MedDRA (26) | Systematic Assessment | Hyperemia was coded as conjunctival hyperemia if it was specifically indicated as occurring in the conjunctiva; all other cases of hyperemia were coded as ocular hyperemia. |
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| Instillation site irritation | General disorders | MedDRA (26) | Systematic Assessment |
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No significant limitations or caveats were reported for the study.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shigenobu Nakazora | D. Western Therapeutics Institute, Inc. | +81-52-218-8785 | shinakazora@dwti.co.jp |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 30, 2024 | Jul 17, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Blue |
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| Green |
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| Hazel |
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| Other |
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| study eyes |
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| Day 28: T0 + 2h, change from baseline (mmHg) |
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| Day 28: T0 + 4h, change from baseline (mmHg) |
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| Day 28: T0 + 8h, change from baseline (mmHg) |
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| Day 28: T0 + 12h, change from baseline (mmHg) |
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| Day 28: 8-hour diurnal, change from baseline (mmHg) |
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| Day 28: 12-hour diurnal, change from baseline (mmHg) |
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